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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC EMERGE MONORAIL BALLOON DELIVERY SYSTEM, 3.0 MM X 20 MM

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BOSTON SCIENTIFIC EMERGE MONORAIL BALLOON DELIVERY SYSTEM, 3.0 MM X 20 MM Back to Search Results
Device Problems Wire (430); Fracture (1260); Difficult to Remove (1528); Physical Resistance (2578)
Patient Problem Reocclusion (1985)
Event Date 01/18/2014
Event Type  Injury  
Event Description

Patient had a cerebral arteriogram and basilar artery endovascular angioplasty with stent and ia tpa for a basilar artery stroke in light of high grade basilar artery stenosis. A boston scientific emerge monorail 3. 0 mm x 20 mm balloon delivery system and neuroscout 0. 014 inch microwire construct was inserted into the sca. The guide catheter was then advanced to the left vertebral artery under fluoroscopic guidance. The microwire was positioned to the right sca vessel. The balloon was advanced to the level of the area of maximal stenosis within the basilar artery. The balloon was inflated to nominal pressure. The balloon was deflated. Attempts to retract the microwire from the right sca were met with resistance. Fluoroscopic imaging identifies the presence of the microwire snagged within the right sca. Multiple maneuvers were performed in an attempt to dislodge the microwire from the right sca. After a significant amount of time engaging in multiple maneuvers to dislodge this microwire. The microwire was then placed under tension which resulted in intentional fracture of the microwire. This fractured microwire and balloon delivery system was then retrieved from the shuttle sheath over the guide catheter. Add'l angiographic imaging identified reocclusion of the basilar artery. The boston scientific emerge monorail 3. 0 mm x 20 mm balloon delivery system and a new 0. 014 inch microwire construct were inserted with the guide catheter advanced into the left vertebral artery under fluoroscopic guidance. Reason for use: basilar artery stroke in light of high-grade basilar artery.

 
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Brand NameEMERGE MONORAIL
Type of DeviceBALLOON DELIVERY SYSTEM, 3.0 MM X 20 MM
Manufacturer (Section D)
BOSTON SCIENTIFIC
MDR Report Key3866735
MDR Text Key19556948
Report NumberMW5036510
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/30/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/04/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? Yes

Patient TREATMENT DATA
Date Received: 06/04/2014 Patient Sequence Number: 1
Treatment
CRESTOR 10 MG DAILY.; CIALIS 20 MG Q.36 HOURS P.R.N.; ZETIA 10 MG DAILY.; ASPIRIN 81 MG DAILY.; VITAMIN B COMPLEX DAILY.; VIAGRA 100 MG DAILY P.R.N.; LISINOPRIL 40 MG DAILY.
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